{"commentary":{"count":73,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":39,"podcast":19,"youtube":15},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT01993979\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"POUT","nct_id":"NCT01993979","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=pout-nct01993979. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":"POUT","arms":[{"description":"Patients allocated to surveillance will be seen at 4, 7, 10 and 13 weeks post randomisation - equivalent to the end of cycle in patients receiving chemotherapy - in order to collect details of early treatment failure in this group and comparative data relating to toxicity and quality of life. Patients on surveillance will then be followed up for signs of recurrence at the same intervals as those who received chemotherapy","label":"Surveillance","type":"OTHER"},{"description":"Patients allocated adjuvant chemotherapy will receive 4 x 21 day cycles of gemcitabine-cisplatin. Patients who have a sub-optimal renal function (GFR 30-49ml/min) will receive carboplatin instead of cisplatin.","label":"Chemotherapy","type":"EXPERIMENTAL"}],"collaborators":["Cancer Research UK"],"completion_date":{"date":"2022-05","type":"ESTIMATED"},"conditions":["Transitional Cell Carcinoma of Ureter"],"enrollment":{"count":261,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Chemotherapy","type":"DRUG"},{"name":"Surveillance","type":"OTHER"}],"last_update":"2020-05-04","lead_sponsor":"Institute of Cancer Research, United Kingdom","official_title":"A Phase III Randomised Trial of Peri-Operative Chemotherapy Versus sUrveillance in Upper Tract Urothelial Cancer","overall_status":"UNKNOWN","phases":["PHASE3"],"primary_completion_date":{"date":"2018-11-07","type":"ACTUAL"},"primary_outcomes":[{"measure":"Disease-free survival (DFS)","timeFrame":"3 years"}],"references":[{"citation":"Birtle A, Johnson M, Chester J, Jones R, Dolling D, Bryan RT, Harris C, Winterbottom A, Blacker A, Catto JWF, Chakraborti P, Donovan JL, Elliott PA, French A, Jagdev S, Jenkins B, Keeley FX Jr, Kockelbergh R, Powles T, Wagstaff J, Wilson C, Todd R, Lewis R, Hall E. Adjuvant chemotherapy in upper tract urothelial carcinoma (the POUT trial): a phase 3, open-label, randomised controlled trial. Lancet. 2020 Apr 18;395(10232):1268-1277. doi: 10.1016/S0140-6736(20)30415-3. Epub 2020 Mar 5.","pmid":"32145825","type":"RESULT"},{"citation":"Birtle AJ, Jones R, Chester J, Lewis R, Biscombe K, Johnson M, Blacker A, Bryan RT, Catto JWF, Choudhury A, Das P, Jagdev S, Powles T, Wagstaff J, Cheung KC, Cafferty F, Hall E. Improved Disease-Free Survival With Adjuvant Chemotherapy After Nephroureterectomy for Upper Tract Urothelial Cancer: Final Results of the POUT Trial. J Clin Oncol. 2024 May 1;42(13):1466-1471. doi: 10.1200/JCO.23.01659. Epub 2024 Feb 13.","pmid":"38350047","type":"DERIVED"}],"start_date":{"date":"2012-05"},"study_type":"INTERVENTIONAL","title":"A Phase III Randomised Trial of Peri-Operative Chemotherapy Versus sUrveillance in Upper Tract Urothelial Cancer (POUT)","url":"https://clinicaltrials.gov/study/NCT01993979"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/pout-nct01993979"}